Memantine for Enhanced Stroke Recovery
|Principal Investigator: JenniferMajersik|
|Keywords: Stroke , Memantine , Motor Recovery , Rehabilitation||Department: Neurology|
|IRB Number: 00068751||Co Investigator: KevinBrennan|
|Specialty: Occupational Therapy, Physical Medicine and Rehabilitation, Neurology|
|Sub Specialties: Stroke , Stroke|
This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm. The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah. An intention to treat model will be used during the study.
Hypothesis 1: Individuals treated with memantine XR for 12 weeks after an acute ischemic stroke will show greater improvements on the Fugl-Meyer Upper Extremity (FMUE) and Fugl-Meyer Lower Extremity (FMLE) than individuals who receive a placebo.
Hypothesis 2: Individuals treated with memantine XR for 12 weeks after an acute ischemic stroke will have no greater serious adverse events than individuals who receive placebo.
Hypothesis 3: Individuals treated with memantine XR for 12 weeks after acute ischemic stroke will show greater improvements in upper extremity (UE) functioning as measure by the Grip Strength Test, Motor Activity Log, and the hand subscale of the Stroke Impact Scale than those who received placebo.
Hypothesis 4: Individuals treated with memantine XR for 12 weeks after acute ischemic stroke will show greater improvements in LE functioning as measured by the Ten Meter Walk Test and the mobility subscale of the Stroke Impact Scale than those who receive placebo.
Hypothesis 5: Individuals treated with memantine XR for 12 weeks after acute ischemic stroke will show greater improvements in activity and participation as measured by the total Stroke Impact Scale than those who received placebo.
- Age 18 and older
- Randomization between 3 days to 8 weeks of stroke symptom onset
- Arm weakness severe enough to warrant inpatient or outpatient occupational therapies
- Able to voluntarily move the affected UE
- Living independently prior to their stroke
- Image-confirmed stroke (MRI or CT)
- Supratentorial location of stroke
- Fugl-Meyer Upper Extremity Score of 50 or less and/or a Fugl-Meyer Lower Extremity Score of 28 or less
- Ability to swallow pills
- Subarachnoid hemorrhage, subdural hemorrhage, or other cause of symptoms other than ischemic or hemorrhagic stroke
- Infratentorial location of stroke (brainstem or cerebellum)
- NIH Stroke Scale >20 at the time of randomization
- History of dementia that will interfere with rehab
- Pre or post-stroke use of memantine or amantadine
- Contraindications to taking memantine XR in pill form
- History of prior clinical stroke with residual symptoms on the same side as the current symptoms that would interfere with outcomes of this study
- Documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment if not done as part of clinical care.
- Moribound or not expected to live 6 months
- Severe cognitive deficits or pre-morbid function causing inaccurate neurologic assessment or inability to complete the initial assessment
- Comorbid neurologic disease expected to interfere with the results. This could include diseases such as Multiple Sclerosis, neurodegenerative diseases, spinal cord disease, and CNS cancer, at the judgement of the PI.
- Documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
- Patients who are pregnant or breast feeding